A Study to Investigate the Effects of GC4419 on Radiation-Induced Oral Mucositis in Patients With Head/Neck Cancer

Overview

About this study

The purpose of this study is to determine if GC4419, administered prior to intensity-modulated radiation therapy (IMRT), reduces the severity of radiation-induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria: 

  • Squamous cell carcinoma of the head and neck.
  • Treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy.
  • Treatment plan to receive standard cisplatin monotherapy.
  • Age 18 years or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Adequate hematologic, renal and liver function.
  • Negative serum pregnancy test.
  • Use of effective contraception.

Exclusion Criteria:

  • Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands.
  • Metastatic disease. 
  • Prior radiotherapy to the region of the study cancer or adjacent anatomical. 
  • Prior induction chemotherapy. 
  • Receiving any approved or investigational anti-cancer agent other than those provided for in this study. 
  • Concurrent participation in another interventional clinical study.
  • Inability to eat soft solid food at baseline.
  • Malignant tumors other than HNC within the last 5 years.
  • Active infectious disease excluding oral candidiasis. 
  • Presence of oral mucositis at baseline. 
  • Known history of HIV or active hepatitis B/C.
  • Female patients who are pregnant or breastfeeding. 
  • Known allergies or intolerance to cisplatin and similar platinum-containing compounds. 
  • Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Byron May, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20467330

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